Cereno’s CEO comments on progress with CS1 and CS014
Cereno Scientific reports new advancements with two of its drug candidates. The phase II study with CS1 in pulmonary arterial hypertension (PAH) has closed patient recruitment, and topline results will be presented in the third quarter of 2024. Furthermore, the first patient has been dosed in the phase I study with CS014, which is being developed for thrombosis prevention. BioStock reached out to CEO Sten R. Sörensen to learn more.
The biotech company Cereno Scientific operates in the cardiovascular field, developing innovative treatments to improve the quality of life and extend the lives of people with both rare and common cardiovascular diseases. The company’s portfolio consists of the drug candidates CS1, CS014, and CS585, which are being evaluated in three parallel development programs. These drug candidates differ from the majority of today’s treatment options as they all aim to address the underlying causes of their respective diseases.
Phase II study with CS1 advances toward topline results
The company’s leading drug candidate, CS1, a histone deacetylase (HDAC) inhibitor acting through epigenetic modulation, is being evaluated in a phase II study for the rare disease pulmonary arterial hypertension. Recently, the company announced that patient recruitment for the study has been completed. The decision to close the study for recruitment was made after the Study Clinical Steering Committee assessed that there is sufficient data to evaluate the next steps in development. The study is now moving towards topline results, which will be presented in Q3 2024. Read more about CS1 and its mechanism of action here.
Clinical development of CS014 initiated
Furthermore, Cereno announced that the first participant has been dosed in the first clinical study of the drug candidate CS014, which is being developed for thrombosis prevention. The phase I first-in-human study will include approximately 48 participants, and results are expected in about a year. Like CS1, CS014 works through HDAC inhibition. Hear the company talk more about the candidate here.
CEO insights
BioStock reached out to CEO Sten R. Sörensen to learn more about the latest developments.
The phase II study with CS1 is now progressing towards topline results. What are the key objectives of the study?
– The primary objective of the phase II study is to evaluate the safety and tolerability of CS1 treatment in patients with PAH. The topline results will also include an assessment of relevant exploratory efficacy measures used in previous studies for this patient group, and results from new innovative methods in this context. Additionally, the study will incorporate a validated risk estimation evaluate and various biomarkers, quality of life, different aspects of heart function, and hemodynamic variables from daily measurements with CardioMEMS. Finally, we expect to determine the optimal dosing for upcoming clinical studies.
What are the plans for the further development of CS1?
– Firstly, we look forward to reporting the topline results in the third quarter of 2024. Once we have these results, we will start interactions with authorities regarding the design of a pivotal study. Since January 30, 2024, CS1 has also been available under the FDA’s Expanded Access Program (EAP), as an extension of the ongoing phase II study evaluating CS1 in PAH. The EAP allows patients who have completed the phase II study of CS1 in PAH, and have been deemed suitable by investigators, to continue CS1 treatment when no comparable or adequate treatment options are available. The program will allow us to collect safety and efficacy data regarding long-term exposure to CS1 in patients with PAH according to a formally approved FDA protocol. This initiative will not only support the treatment of PAH patients but also enable Cereno to gather additional documentation of CS1 usage ahead of the aforementioned discussions with authorities.
Are the topline results Cereno’s next trigger or what else is on the horizon?
– Reporting topline results for CS1 in the rare disease PAH is our most important milestone in the coming months. At the same time, we are also working towards dosing the first patient within the framework of the Expanded Access Program for CS1 in PAH.
The first participant has been dosed in the phase I study with CS014. What does the study’s timeline look like and what specific results do you hope to achieve in the coming year?
– Now that the first participant in the phase I study of CS014 has been dosed, the study will proceed in two phases. The is a single-dose part with dose escalation to evaluate safety, tolerability, and pharmacokinetics of an oral single dose of CS014. The second phase is repeated dosing with dose escalation to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics with repeated dosing of CS014 over seven days. Results from the phase I study are expected in about a year’s time.
How do these clinical advancements impact the overall development of Cereno Scientific?
– Reaching important milestones is crucial for both our financing and the company’s business development. We are now actively working to increase visibility for Cereno and our candidates among potential investors and pharmaceutical companies. Earlier this summer, I attended the major industry conference BioInternational in San Diego, where I had many interesting meetings and experienced significant and growing interest in Cereno and our development portfolio.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
